No other novel urinary molecular markers or biomarker tests are currently routinely used or guideline recommended for diagnosis or follow up of bladder cancer.
Conclusions from EAU guideline:
- Sensitivity is usually higher, at cost of specificity
- Benign conditions and previous BCG can influence results
- Sensitivity and specificity may vary widely depending on clinical context (screening vs symptomatic vs follow up)
- Wide range of results and low reproducibility may be explained by complicated laboratory methods and patient selection
- Positive results may identify patients more likely to have recurrence +/- progression
No urinary marker can currently replace cystoscopy in the diagnosis or follow up surveillance of bladder cancer
Cell based:
UroVysion – FISH assay detecting aneuploidy in chromosomes 3, 7 and 17 and loss of 9p21
CxBladder – cell based urine assay comprising 5 mRNA fragments
ImmunoCyt – fluorescent labelled antibodies directed against three antigens expressed by exfoliated urine cells – glycosylated CEA, and two mucins.
Protein based:
BTA – bladder tumour antigen assay, detecting two basement membrane antigens using monoclonal antibodies – can be used as a dipstick test
NMP22 – nuclear matrix protein 22 provides structure to cell nucleus, and is 20x more prevalent in malignant cells cf. normal urothelial cells.
AUA – UroVysion FISH and ImmunoCYT may help adjudicate equivocal cytology and may be used to assess post BCG response.
CxBladder Monitor probably has the most promising role with 93 % sensitivity and 97 % negative predictive value for recurrence NMIBC in surveillance – therefore negative test could probably mean avoiding cystoscopy – but non-negative tests generally still requiring cystoscopy.